Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LeMaitre Single Lumen Embolectomy Catheter 5F Recalled by LeMaitre Vascular, Inc. Due to Manufacturing issue that could cause a pinhole in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LeMaitre Vascular, Inc. directly.
Affected Products
LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.
Quantity: 4315 total
Why Was This Recalled?
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About LeMaitre Vascular, Inc.
LeMaitre Vascular, Inc. has 69 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report